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The Food and Drug Administration will review the study proposals from third parties and make recommendations on selection.
DePuy, Zimmer and another producer of metal hips, Wright Medical, declined to discuss the study proposals they had submitted to the F.D.A. to comply with its May order.
When researchers wish merely to share biospecimens across institutions but not participate in the new uses of those specimens once they are shared, most ADs indicated that their IRBs would not need to review information regarding the study proposals or IRB approvals from the outside institutions when biospecimens are anonymized or coded.
The success rate for our sample of Basic Science proposals was higher than the official success rate (31% vs 19%), and for Public Health, the success rate was lower (11% vs 13%), indicating some difference in the calibre of the study proposals with the wider population of proposals.
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The study proposal was presented to the department board review and the ethics committee.
The Medical University of South Carolina Institutional Review Board approved the study proposal.
The study proposal was approved by the BPNSU executive committees.
The study proposal was reviewed and approved by the National Defense Medical Center Institutional Review Board.
MS was responsible for the drafting of the study proposal.
The study proposal has been approved by the Ethics Committee of Hazrat e Rasoul Hospital.
The study proposal was approved by the Institutional Review Board of Okinawa Chubu Hospital.
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